标准理解常见过程清单.ppt

ISO/TS 16949 的重要要求,ISO/TS 16949：2009- 常见的过程清单,Generic Process listing: 常见过程清单,1. Sales 销售 2. Product Design 产品设计 3. Product Development 产品开发 4. Facility Management 设备维护 5. Human Resources 人力资源 6. Materials Management 材料管理 7. Production Related 生产相关 8. Quality Assurance 质量保证 9. Delivery 交付 10. Post-Delivery 交付后的活动 11. Business Management 业务管理,用顾客指定的语言及格式沟通的能力 Customer Specific Requirements: Not just Big 3! 顾客的特殊要求：不仅仅局限在三大汽车公司 Designated “Customer Representative”. 指定顾客代表 Manufacturing Feasibility including risk analysis at Contract Review Stage. 制造可行性包括在合同评审阶段的风险分析 Customer Products, Projects and related information to be maintained confidential. 确保顾客信息保密（产品、项目及其它相关信息） Waiver of formal review requirements under special circumstances to be authorized by customer. 在特定条件下放弃正式的评审要求，要有顾客的授权。,1. Sales related Process: 销售相关的过程,2.Product Design Process: 产品设计过程（1/6）,Product Design Personnel to be competent to achieve design requirements & skilled in applicable tools and techniques. (eg.CAD/DFM/DFA/DOE/CAE/DFMEA/PFMEA/FEA/GD & T/QFD/Reliability Engg. Plans/Simulation techniques/Solid Modeling/Value Engineering etc.) 确保负有产品设计职责的人有能力达到设计要求并熟练掌握适用的工具和技术（例如计算机辅助设计，制造性设计，装配性设计，试验设计，计算机辅助工程，设计FMEA，过程FMEA，有限元分析，几何尺寸和公差，质量功能展开，可靠性工程计划，仿真技术，实体造型，价值工程等。） Organization to define necessary tools and techniques. 组织必须识别适用的工具及技术 Focus of Design & Development on Error Prevention rather than detection. 设计和开发更关注防错，而不是探测。,2.Product Design Process: 产品设计过程（2/6）,Design Planning to include determination of : 在进行设计和开发策划时，组织必须决定： Design & Development Stages. 设计和开发阶段 Review, Verification & Validation appropriate at each stage. 适于每个阶段的评审，验证和确认活动 Responsibilities and Authorities for D & D. 设计和开发的职责和权限 Interfaces to be Managed and Communication to be ensured between different working groups. 对不同工作小组的接口进行管理，以确保有效的沟通。 Consideration to be given to Customer Requirements & reference to its technical specifications to be included in the appropriate quality plan. 本技术规范相关的顾客要求及参考应在适当的质量计划中体现。,Product Design Inputs to be identified, documented & reviewed for adequacy include: 组织必须对产品输入要求进行识别，形成文件并进行评审，应包括以下内容： Functional & Performance requirements. 功能和性能要求 Applicable Statutory & Regulatory requirements. 适用的法律法规的要求 Customer requirements such as SCs identification, traceability and packaging. 顾客要求，例如特殊特性，标识，可追溯性和包装 Information from previous similar design projects, competitor analysis, supplier feedback, internal I/P, field date and other relevant sources Process for deployment of such information to be in place. 从以前的设计项目，竞争对手分析，供方反馈，内部输入，市场数据和其它相关资源中获得信息，应有过程展开这些信息。 Targets for Product Quality ,Life, Reliability, Durability, Maintainability, Timing & Cost. 产品质量，寿命，可靠性，耐久度，可维护性，时间计划和成本的目标,2.Product Design Process: 产品设计过程（3/6）,2.Product Design Process: 产品设计过程（4/6）,Product Design Outputs to be expressed in terms that can be verified and validated against product design input requirements include: 产品设计输出必须以能根据产品输入的要求，进行验证和确认的方式来表示，产品设计输出必须包括： Design FMEA, Reliability results. 设计FMEA,可靠性结果 Product Special Characteristics and Specifications including conformance to Customer requirements for designation, documentation & control. 产品特殊特性和规范与顾客要求的制定，文件及控制相一致 Product Error Proofing as applicable. 产品防错，适当时 Product Definition including drawing or math based data. 产品定义，包括图纸，数学数据 Product Acceptance Criteria ZD for attribute data customer approval where required. 产品的接受标准，要求时，必须由顾客批准。计数型数据必须为零缺陷,2.Product Design Process: 产品设计过程（5/6）,Product Design Outputs to be expressed in terms that can be verified and validated against product design input requirements include: 产品设计输出必须以能根据产品输入的要求，进行验证和确认的方式来表示，产品设计输出必须包括： Product Design reviews results. 产品设计评审结果 Diagnostic Guidelines where applicable. 诊断指南，适当时 Provision of appropriate information for purchasi production and for service provision. 为采购，生产和服务提供适当的信息,2.Product Design Process: 产品设计过程（6/6）,MDT approach to be evidenced in the identification of Special Characteristics, development & review of DFMEA including actions to reduce potential risks. 组织必须在以下工作中使用多方论证的方法：特殊特性的识别，确认；DFMEA的开发和评审，包括采取降低潜在风险的措施 Consideration to be given to Product Safety and means to minimize potential risks to employees in the D&D process. 在设计过程中应考虑产品的安全性及雇员风险的最小化的方法,Concept of “Design & Development” to be applied to Product as well as Manufacturing Process. 应用在产品上的“设计和开发”概念同样适用于制造过程。 Manufacturing Process Design Inputs to be identified, documented & reviewed for adequacy include: 组织必须对过程设计的输入要求进行识别，形成文件并进行评审，包括： Product Design Output data. 产品设计输出的数据 Targets for Productivity, Process Capability and cost. 生产率，过 程能力和成本的目标 Applicable Statutory, Regulatory & Customer requirements if any. 适用的法律法规及顾客的要求，如果有。 Experience from previous developments. 以往的开发经验,3.Product Development Process:产品开发过程（1/9）,3. Product Development Process: 产品开发过程（2/9）,Manufacturing Process Design Outputs to be expressed in terms that can be verified and validated against manufacturing process design input requirements & validated include: 过程设计输出必须能根据过程输入的要求，进行验证和确认的方式来表示，过程设计输出必须包括： Specifications & Drawings.规范及图纸 Manufacturing Process Flow Chart/Layout. 制造过程流程图/场地平面布置图 Manufacturing Process FMEAs . 制造过程FMEA Control Plan.控制计划 Work Instructions.作业指导书 Process Approval acceptance criteria-ZD for attributes& approved by customer where required. 过程的接受标准，要求时，必须由顾客批准。计数型数据必须为零 缺陷, Manufacturing Process Design Outputs to be expressed in terms that can be verified against manufacturing process design input requirements & validated include: 过程设计输出必须能根据过程输入的要求，进行验证和确认的方式来表示，过程设计输出必须包括： Data for Quality, Reliability, Maintainability and Measurability. 有关质量，可靠性，可维护性及可测量性的数据 Results of error proofing activity, as appropriate. 防错活动的结果，适当时 Methods of Rapid Detection and feedback of product/Manufacturing Process Non-conformity. 产品/制造过程中不合格的快速探测及反馈方法,3.Product Development Process:产品开发过程（3/9）,3. Product Development Process:产品开发过程（4/9）, MDT approach to be evidenced in the development & review of PEMEA including actions to reduce potential risks and in the development and review of control plans. 组织必须在以下方面采用多方论证的方法： PEMEA的开发及评审，包括为降低潜在风险而采取的措施。控制计划的评审 Consideration to be given to Product Safety and means to minimize potential risks to employees in the Mfg. process design activities. 在过程开发和生产活动中，必须关注产品安全和员工潜在危险最小化的方法。 Process Control Documents to be marked with customer special Characteristics symbol or equivalent. 组织必须在过程控制文件中使用顾客要求的或等同的符号作对应的标识。 Special Characteristics includes process parameters. 特殊特性包括过程参数,Design & Development review and monitoring to be done in accordance to the planned arrangements to: 必须根据策划的安排对设计和开发进行评审和监测： Evaluate ability of the results of the Design & Devpt.to meet requirements. 评价设计和开发结果符合要求的能力。 To identify and problems and propose necessary actions. 识别任何问题并提出必要的措施 Measurements at specified stages in the design and development to be defined, analysed and reported. This includes: 在设计和开发指定阶段的衡量准则必须被定义，分析和报告。 这些衡量准则包括： Quality Risks, Costs, Lead Times, Critical Paths etc. 质量风险，成本，准备时间，关键路径等。 Summary of Measurements to be provided to and reviewed by Management. 衡量准则的概括总结应该作为管理评审的输入。,3.Product Development Process:产品开发过程（5/9）,Verification to be done in accordance to planned arrangements to confirm that outputs have met the input requirements. Includes Product and Manufacturing process. 为确保输出符合输入的要求，必须根据计划的安排对产品开发过程进行 验证。该要求适用于产品和制造过程。 Verification results to be maintained together with those of necessary actions. 验证结果及必要措施的记录必须予以保持。,3.Product Development Process:产品开发过程（6/9）, Validation to be done in accordance to planned arrangements including customer requirements and program timing-to be monitored for timely completion and conformity to requirements. 必须根据计划的安排对产品的开发过程进行确认，计划应包括顾客的要 求和项目时间为确保符合要求和及时完成而采取的监测。 Product Validation to confirm suitability of product to meet requirements for specified a application or intended use. 产品确认的目的是确保产品能够满足规定的要求，或已知的预期用途的 要求,3.Product Development Process:产品开发过程（7/9）, Product Validation process normally includes an analysis of field reports for similar products. 产品确认过程通常包括类似产品的市场报告的分析 Validation results to be maintained together with those of necessary actions. 确认结果及必要措施的记录必须予以保持。 If required by customer, prototype program and control plan to be developed by organization. 当顾客要求时，组织必须开发样件计划和控制计划。 Suppliers, Tooling and Mfg processes used for prototype to be used for production same as far as possible. 样件生产采用的供方，使用的工装和制造过程应尽可能和正式生产保 持一致。 Technical leadership of outsourced services relating to verification and validation to be assumed by the organization. 组织必须提供与验证和确认相关的外包服务的技术指导。,3.Product Development Process:产品开发过程（8/9）, Product and Manufacturing process approval procedure used should be one that is recognized by the customer. 必须使用顾客认可的产品和制造过程批准程序。 Produce approval is subsequent to the verification of the manufacturing process. 产品批准应该是制造过程验证的后续步骤。,3.Product Development Process:产品开发过程（9/9）, Permanent & Visible labeling of Customer Owned Tools & Equipment. 对顾客拥有的工具和设备必须作永久和明显的标识。 Multi Disciplinary approach towards plant, facility & Equipment Plans. 采用多方论证的方法制定工厂，设施及设备的计划。 Layouts to optimize material travel, handling & value added use of floor space. 工厂的平面布置必须优化材料搬运，以及对场地面积的增值使用。 Layouts to facilitate synchronous material flow. 工厂的平面布置必须促进材料的同步流动。 System to monitor the effectiveness of existing opns focus on Lean Mfg.& linked to QMS effectiveness. 对现存作业有效性的评价应该关注精益制造以及与质量管理体系的有效性相联系。 House Keeping.库房管理 Contingency.应急,4. Facility Management Process:设备管理过程（1/2）, System for tooling management to be in place including Engineering change level on tool design modification documentation. 工装管理系统中必须包括工装设计变更文件化，如工程变更等级。 Systems needed to monitor Outsourced tooling activities. 系统需要对工装外包活动进行监控。,4.Facility Management Process:设备管理过程(2/2),Documented procedure mandated for “training”. 培训的文件化程序 Enhanced focus on Competency & Skills-OJT. 强调关注能力和技能在职培训 Training to focus on “customer Requirements”. 培训关注“顾客要求” Soft aspects introduced:软件方面的介绍 Motivation for Achievement/Continual Improvements/Innovation. 在持续改进、创新方面的动力。 Promotion of Quality & Technological awareness. 质量和技术意识的提高。 Relevance and importance of job relative to obj. 与质量目标相关的工作的相关性和重要性。 Consequences of NC to customer. 不符合顾客质量要求的后果。,5.Human Resources Process:人力资源过程(1/2), Measurement system in place to monitor employee understanding of their positions impactsand how their position ties to the fulfillment of the Quality Objectives. 必须有过程测量和监控员工对本职岗位的影响及和如何将本职岗位与 实现质量目标联系在一起。 Contract/Agency Personnel performing work affecting Product Quality to be covered. 合同工和代理工作人员在执行影响产品质量的工作时同样适用该过程。 Personnel responsible for product quality to available in all working shifts. 所有班次必须有负责产品质量的工作人员。,5.Human Resources Process:人力资源过程(2/2),Organization to ensure that purchased product conforms to specified purchase requirements. 采购的产品必须符合指定的采购要求 Suppliers to be selected based on their ability to supply products in accordance with the organizations requirements. 必须根据供方按组织的要求，提供产品的能力选择供应商。 Criteria for selection, evaluation, and re-evaluation to be established and records maintained. 选择，评估，再评估的准则应予以建立，相关的记录应予以保存。 Procured material to conform to applicable regulatory requirements. 所获得的原材料均需满足适用的法律法规要求。 When specified by contract, procurement of products, materials or services to be done form approved sources. 若合同中规定，必须从经过核准的供方处采购产品，材料或服务。 Onus of ensuring quality of purchased products even from customer approved sources is with the organization. 从顾客核准的地方采购产品不能免除组织确保采购产品质量的责任。,6.Materials Management Process:材料管理过程(1/4), Organization to perform Supplier Quality Management System development. 组织执行供方质量体系开发工作。 “Supplier”-sites where production and/or service parts specified by the customer are manufactured. 供方一提供顾客指定零件生产和服务的地方。 Goal of Supplier development-Supplier conformance with ISO/TS16949:2002. Conformance with ISO9001:2000 is the first step. 供方开发目标一符合ISO/TS16949：2002。 符合ISO9001：2000是达到目标的第一步。 Supplier to be third party registered to ISO9001:2000 unless otherwise specified by the customer. 除非顾客有特定的要求，否则供方必须通过第三方认证机构ISO9001:2000认证。 Customer Recognized “Product & Manufacturing process approval procedure” to be applied to suppliers. 顾客认可的“产品和生产过程核准程序”同样适用于供方。,6. Material Management Process:材料管理过程(2/4), Supplier Performance to be monitored through the following indicators: 通过以下指标监控供方的绩效。 Delivery Product Quality.交付产品的质量。 Customer Disruptions including field returns. 对顾客造成的中断干扰，包括市场退货。 Delivery Schedule performance (including incidents of Premium Freight). 交付时间表现（包括发生的超额运费） Special Status Customer Notification related to Quality or Delivery Issues. 与质量和交付问题有关的特殊状态顾客通知 Organization to promote Supplier Monitoring of their Manufacturing Process. 组织必须促进供方监测自身的制造过程。,6. Material Management Process:材料管理过程(3/4), Incoming product quality to be assured though one or more of the following methods: 通过以下一种或多种方法确认进料产品的质量。 Receipt of, and evaluation of statistical date by the Organization. 组织接受并评价统计数据。 Receiving Inspection and /or testing such as sampling based on performance. 接收检验/或测试，例如基于性能的抽样。 Second or their party audits of supplier sites records of acceptable delivered product quality. 第二或第三方对供方现场的审核已接受产品的质量记录。 Part evaluation by a designated laboratory. 由指定试验室对零件进行评估。 Any other methods agreed with customer. 任何其他顾客同意的方法。 Continuity of Suppliers QMS and its effectiveness to be verified in the event of mergers, acquisitions or affiliations. 当发生合并，收购或联营时，验证供方质量管理体系的有效性和 连续性。,6 Materials Management Process:材料管理过程(4/4), Production Scheduling to meet customer reqmt. 符合顾客要求的生产排程。 JIT supported by an information system that permits access to production information at key stages of process. 由信息系统支持的准时生产，该系统允许在关键阶段使用生产信息。 Order Driven.订单驱动 Process studies to be done on all new Manufacturing process to verify process capability and provide additional input for process control. 对所有新的过程进行研究以确认过程能力，并为过程控制提供额外的 输入 Results of process studies to be documented with specifications, where applicable, for means of production measurement and test and maintenance instructions. 过程研究的结果文件化，适当时附有生产方法，测量和试验以及维护 指导书等规范。, Documents to include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria 文件包括制造过程能力，可靠性，可维护性和可获得性的目标及其 接收准则。 Manufacturing activities to be carried out in accordance to controlled conditions as appropriate. 适当的生产活动在受控条件下进行。 Control Plans to be developed at the system,subsystem, component and/or material level for the product supplied, including those for processes producing bulk materials as well as parts. 针对所提供的产品在系统，子系统，部件和/材料各层次上开发控制计划，包括生产散装材料和零件的过程。 Pre-launch and Production Control Plans to take into account DFMEA & PFMEA outputs. 试生产和生产的控制计划要考虑DFMEA & PFMEA的输出。,7. Production Related Process:生产相关过程(2/6), Control Plan format provided in Annex A includes amongst other requirements: Customer Information,Process Related special characteristics, error-proofing & corrective action. 附件A提供的控制计划将一些其他的要求包括在其中：顾客信息，与过程相关的特殊特性。防错和纠正措施。 Control Plans to: 控制计划： List controls used for Manufacturing Process Control. 列出用于制造过程控制的控制方法。 Include methods of monitoring of control exercised over Special Characteristics Organization or Customer determined. 包括监测由顾客和组织共同定义的特殊特性控制的方法。 Control Plan to be reviewed and updated when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA. 当任何影响产品，制造过程，测量，物流，物资供应或FMEA的更改发生时，必须重新评审和更改控制计划。,7.Production Related Process: 生产相关过程(3/6), Operating Instructions derived from such as Control Plans & Quality Plans to be documented and made accessible for use at the work station. 作业指导书来自控制计划和质量计划，应该将作业指导书文件化，并确保在生产区域易于取得。 Work instructions to be available where applicable. 作业准备的作业指导书应易于取得。 Statistical methods to be adopted where applicable. 适用时可以采用统计方法。 Job set-ups to be done whenever performed, such as initial run of a job, material changeover or job change. 无论何时实施（如作业的初步运行，材料更换或作业更改），均需实施作业准备验证。 Manufacturing Process capability or performance as specified by customer part approval process requirements to be maintained. 必须保持顾客生产件批准程序规定的过程能力或性能。,7. Production Related Process: 生产相关过程(4/6), Significant process events such as tool change or machine repair to be recorded. 记录重要的过程事件，例如工具更换，设备维修。 Reaction plans to be initiated for not capable /unstable characteristics. 特性不稳定或不具有统计能力时，启动反应计划。 Records of process change effective dates to be maintained. 维护过程更改生效日期的记录。 Product and Product States identification to be maintained at all stages, unless inherently obvious. 在产品实现的所有阶段识别和维护产品和产品的状态，除非产品 本身状态明显。 Predictive and Prevent Maintenance Measures to be in place. 运用预知性和预防性维护保养方法。,7.Production Related Process: 生产相关过程(5/6), Periodic stock assessment to be done. 定期检查库存。 Stock Rotation system required. 库存周转系统是必须的。,7. Production Related Process:生产相关过程(6/6),External Labs used to be either Customer Approved or accredited to ISO/IEC 17025. 外部实验室被顾客核准，或通过ISO/IEC 17025. Reaction Plans to include containment of product and 100% inspection. 反应计划包括遏制产品和100%检验。 Corrective Action Plans to be drawn up. 拟定纠正措施计划。 Obsolete products to be controlled in a manner similar to NC products. 可疑产品控制方法和不合格产品控制相同。 Basic calibration system to be in place. 基础的校准系统。 MSA requires the statistical checking system on Measuring and test equipment. MSA要求对测量和试验设备使用统计学的校验系统。,8.Quality Assurance Process:质量保证过程(1/3),Analytical Methods and Acceptance criteria in line with Customer requirements or alternate methods if approved by customer. 分析方法和接收准则符合顾客要求或顾客批准的同等方法。 Internal labs to be covered by a Lab Scope. 内部实验室涵盖在实验室范围内。 Appropriate statistical tools to be used at all stages. 在所有阶段使用适当的统计学工具。 Knowledge of Statistical tools to be demonstrated organization-wide. 统计学工具的知识在组织范围内体现。 Non-conforming products are those with “unidentified or suspect status”. 不合格品包括“不确定或可疑状态的产品”,8. Quality Assurance Process: 质量保证过程(2/3),Documented rework instruction to be available. 易于得到文件化的返工作业指导书。